Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Continuous Chromatography: Experts Weigh in on the Possibilities and the Reality

Discussions of continuous processing in the biopharmaceutical industry are an important part of current efforts toward intensifying bioproduction and bioprocessing. Biomanufacturers are looking at all components of their development and manufacturing processes for ways to reduce the size of their facilities, lower costs, and increase speed and flexibility of operations. Increasing options for and availability of single-use technologies have been major enablers of myriad attempts to improve efficiencies. Although the general consensus may still be that single-use components are more conducive to continuous upstream than to downstream processing, process intensification efforts to streamline manufacturing operations already have been challenging those assumptions in the past few years. Through new sensors, automation, and process control technologies, biomanufacturers can take advantage of greater connectivity of unit operations (1). Some are implementing hybrid processes (combining both continuous and batch unit operations throughout a manufacturing process), a few are attempting fully continuous unit operations, and many continue to use end-to-end processes based on staggered batch unit operations.

Focusing on downstream efforts to develop continuous processes, some people believe that “continuous production appears to be the first system that will see large-scale implementation because it still leverages the selectivity offered by conventional chromatography resins” (2). Here we look at some key issues and current progress behind implementation of continuous chromatography. It offers a means to overcome batch-column limitations by using membranes or multiple columns that operate continuously in different phases of a manufacturing cycle — or even by running a resin slurry through modular stages that perform chromatographic operations simultaneously in a steady state. The latter is said to increase yield and purity while reducing buffer consumption and facilitating advanced process analytical technology (PAT) and process control implementation (3).